The following presentations were delivered as part of a BioMed21 workshop held at the National Institutes of Health in Bethesda, Maryland on June 26-27, 2017.
Introduction & Adverse Outcome Pathways (AOPs) as an information support system
Catherine Willett, Director, Regulatory Toxicology, Risk Assessment and Alternatives, The Humane Society of the United States & Humane Society International, United States
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View the presentation: Adverse Outcome Pathways (AOPs) as an information support system
Dr. Willett is a member of the Society of Toxicology (SOT), serves on the U.S. National Toxicology Program Scientific Advisory Committee on Alternative Toxicological Methods, served on the board of the former International QSAR Foundation, serves on the Scientific Advisory Board of the Institute of In Vitro Sciences, and is on Shell’s Animal Testing Review Panel. Learn more about Dr. Willett’s current role and research activities »
BioMed21: A human pathways approach to disease research
Christopher Austin, MD, Director, National Center for Advancing Translational Sciences at the US National Institutes of Health, United States
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Dr. Austin is the director of the National Center for Advancing Translational Sciences (NCATS) at the US National Institutes of Health (NIH), where he leads the Center’s work to improve the translation of observations in the laboratory, clinic and community into interventions that benefit patients—from diagnostics and therapeutics to medical procedures and behavioral changes. In 2016, Dr. Austin was elected chair of the International Rare Disease Research Consortium (IRDiRC). Dr Austin is trained as a clinician and geneticist. He completed a research fellowship in developmental neurogenetics at Harvard, studying genetic and environmental influences on stem cell fate determination. He earned an MD from Harvard Medical School and graduated summa cum laude with a AB in biology from Princeton University.
Challenges and needs to use existing data in drug development
François Pognan, Executive Director in Biochemical and Translational Safety, Novartis Pharma, Switzerland
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For more than 25 years, Dr. Pognan’s entire focus has been the understanding and prediction of drug-induced toxicity mechanisms using a variety of tools, ranging from in vitro methods to in vivo investigative studies, and to in silico approaches. He holds a PhD in Molecular Oncogenesis from University Pierre and Marie Curie in Paris, and after a post-doc in Rhone-Poulenc-Rorer, has held various mechanistic toxicology positions in Pfizer-France, AstraZeneca UK & the US Dr Pognan is currently based in Novartis-Pharma in Switzerland as the executive director of pre-clinical safety. He coordinates two European IMI consortia: eTOX – Expert Systems for in Silico Drug Toxicity Prediction and eTRANSAFE – Enhancing Translational Safety Assessment through Integrative Knowledge Management.
NIEHS-led US roadmap to implementation of alternatives
Warren Casey, Director of National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and Executive Director of the US Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), NIEHS, United States
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Dr. Casey is the Director of National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and Executive Director of the US Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). Dr. Casey received his undergraduate degree in biochemistry and his PhD in microbiology from North Carolina State University (NCSU), where he has been named a Distinguished Alumnus and also holds an adjunct professorship in the Department of Microbiology. He currently serves as the vice president of the Society of Toxicology (SOT) In Vitro and Alternative Methods Specialty Section and co-chairs the Organisation for Economic Co-operation and Development (OECD) Validation Management Group – Non Animal.
Clinical Point of view: current practices, challenges and needs
Bruce Cuthbert, Director, National Institute of Mental Health’s Research Domain Criteria Initiative (RDoC), NIMH, United States
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Dr. Cuthbert leads the Research Domain Criteria (RDoC) Unit at the National Institute of Mental Health (NIMH). Dr. Cuthbert returned to NIMH in 2009 following four years as a professor of clinical psychology at the University of Minnesota. He had previously served as Chief of the Adult Psychopathology Research Branch at NIMH. He received his PhD in clinical psychology and psychophysiology from the University of Wisconsin-Madison. He is known for his research on the psychophysiology of emotion, and his translational research on the psychopathology of anxiety disorders. He was elected president of the Society for Psychophysiological Research in 2004 and is a fellow of the Association for Psychological Science.
Primary FDA collaborations for addressing practical applications
Suzanne Fitzpatrick, Senior Advisor for Toxicology, CFSAN, FDA, United States
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Dr. Fitzpatrick is the Senior Advisor for Toxicology in the Office of the Center Director at Center for Food Safety and Applied Nutrition (CFSAN) at the US Food and Drug Administration (FDA) where she is in charge of all toxicology research. Dr. Fitzpatrick represents CFSAN on many FDA Committees and Work Groups including the FDA/NCATS/DARPA Collaboration on Organs/Human on a Chip. She represents FDA at several outside committees, including ILSI HESI Emerging Issues, the OSTP Subcommittee on Toxics and the Environment, the Federal Children’s Environmental Health Task Force and several OECD Committees. Dr. Fitzpatrick is an Adjunct Professor at Johns Hopkins University. She received her BA from the University of California at San Diego and her PhD from Georgetown University.
Using 21st century tools to support compound development: A case study with potential cancer therapeutics
Rebecca A. Clewell, Chief Scientific Officer, ScitoVation, United States.
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Dr. Clewell has more than 15 years of experience in developing in silico and in vitro models to inform chemical safety decisions. Dr. Clewell received her PhD in environmental science and engineering from the University of North Carolina at Chapel Hill. In 2016, Dr. Clewell and several colleagues started ScitoVation, a research group focused on developing tools and methodologies to support in vitro based risk assessments. Together with in vitro-in vivo extrapolation (IV-IVE) and exposure modeling, these cell-based methods are designed to provide a point of departure for safety assessments based solely on biologically relevant in vitro data.
Using organoids to define key pathways in COPD pathogenesis
Ian Adcock, Professor of Respiratory Cell and Molecular Biology, Imperial College London, United Kingdom
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Prof. Ian Adcock is Professor of Respiratory Cell and Molecular Biology at Imperial College, London, UK. He is co-leader of the IMI-funded UBIOPRED project (Unbiased biomarkers in prediction of respiratory disease outcomes). He is Principal Investigator in the MRC/Asthma UK Asthma Centre in Allergic Mechanisms of Asthma, holds an honorary research position at the Royal Brompton Respiratory Biomedical Research Unit and heads the European Respiratory Society Assembly on Airways Disease. Prof Adcock obtained his degree in Biochemistry & Physiology from the University of London and PhD in Pharmacology from St. Thomas’ Hospital London.
Organs on Chips: A Platform for Advancing Drug Development and Disease Modeling
Daniel Levner, Chief Technology Officer, Emulate, Inc. United States
Presentation slides not available
Dr. Levner is Chief Technology Officer at Emulate, Inc., a company that is creating a new living system that emulates human biology, for understanding how different diseases, medicines, chemicals and foods may affect human health. Prior to joining Emulate’s founding team, Dr. Levner was a Senior Staff Scientist with the Wyss Institute for Biologically Inspired Engineering at Harvard University, where he led the advanced engineering team responsible for developing Emulate’s Organs-on-Chips platform. Dr. Levner received his PhD in electrical engineering from Stanford University as well as an MS in aeronautics and astronautics, also from Stanford.
LINCS: Example of Handling Multimodal data and Integration
Ajay Pillai, Co-Chief, Library of Integrated Network-based Cellular Signatures (LINCS), NIH, United States
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Dr. Pillai joined the National Human Genome Research Institute’s (NHGRI) Division of Extramural Research in 2007. He is a member of the Informatics program within the Institute and is deeply involved in a number of trans-NIH efforts like the Common Fund programs Library of Integrated Network-based Cellular Signatures (LINCS), which he co-manages; The Human BioMolecular Atlas Program (HuBMAP) and Big Data to Knowledge (BD2K) program. His main interests and expertise are in computational biology and informatics. Dr. Pillai received a MSc in Physics from Indian Institute of Technology, Kanpur, India and he has a PhD in Physics from The University of North Carolina at Chapel Hill.
Biomedical Data Translator – What’s it going to take?
Christine M. Colvis, Director, Drug Development Partnership Program, NCATS, NIH, United States
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Dr. Colvis is the current Director of the Drug Development Partnership Program at the National Center for Advancing Translational Sciences (NCATS). She joined NCATS in June 2012 to lead the “NIH-Industry Pilot Program: Discovering New Therapeutic Uses for Existing Molecules” that tests a new model for public-private partnership collaborations. Dr. Colvis also oversees the NCATS Biomedical Data Translator program, which launched in 2016 with an initiative to assess feasibility and architectural design of a system that would enable new insights into the biology of disease to improve translation.
Translator and Fanconi Anemia
Christopher G. Chute, Bloomberg Distinguished Professor of Health Informatics, Professor of Medicine, Public Health, and Nursing at Johns Hopkins University, and Chief Research Information Officer for Johns Hopkins Medicine, Johns Hopkins University, Maryland, United States
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Dr. Chute is the Bloomberg Distinguished Professor of Health Informatics, Professor of Medicine, Public Health, and Nursing at Johns Hopkins University, and Chief Research Information Officer for Johns Hopkins Medicine. He received his undergradguate and medical training at Brown University, completed his internal medicine residency at Dartmouth, and completed his doctoral training in epidemiology at Harvard. Dr. Chute is currently the principal investigator of the National Center for Advancing Translational Sciences’ (NCATS) Translator TransMed grant and deputy director of the CTSA program at Johns Hopkins University. He has been active on many HIT standards efforts and currently chairs the World Health Organization (WHO) ICD-11 Revision.
Tox21 and beyond for pharma and biomed
Anton Simeonov, Scientific Director, Intramural Division of Preclinical Innovation at NCATS, NIH, United States
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Dr. Simeonov is the scientific director of the intramural Division of Preclinical Innovation at the National Center for Advancing Translational Sciences (NCATS), NIH. He received a PhD in bioorganic chemistry from the University of Southern California and a BA in chemistry from Concordia College. Dr. Simeonov trained as a postdoctoral fellow at the Scripps Research Institute under Richard Lerner and Kim Janda. Prior to joining NIH in November 2004, Dr. Simeonov was a senior scientist at Caliper Life Sciences, a leading developer of microfluidic technologies, where he was responsible for basic research on novel assay methodologies and development of microfluidic products for research and clinical diagnostics.
Organs on a chip: applications for testing and research
Lucie Low, Scientific Program Manager, NIH Microphysiological Systems Program, NCATS, NIH, United States
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Dr. Lucie Low joined the National Center for Advancing Translational Sciences (NCATS) in 2016 as the Tissue Chip Program Manager for the NIH Microphysiological Systems program. Previously, she was a research fellow at NCCIH and a postdoctoral fellow in Montreal at McGill University, investigating the neuroscience of chronic pain and its effects on brain structure and function. She received a BS from Oxford University (UK) and completed her Masters and PhD in neuroscience at University College London (UK).
Primary Cell-Based Phenotypic Profiling for Building Human Outcome Pathways
Ellen L. Berg, Chief Scientific Officer, DiscoverX, BioMAP Division, United States
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Dr. Berg earned her PhD from Northwestern University and completed a postdoctoral research at Stanford University. Following positions at BioSeek and Protein Design Labs, she became Chief Scientific Officer at DiscoverX, BioMAP Division in September 2016. She is an Society for Laboratory Automation and Screening (SLAS) fellow, serves on the board of the American Society of Cellular and Computational Toxicology (ASCCT), and is a member of the Society of Toxicology (SOT) and the Inflammation Research Association (IRA). Dr. Berg’s research interests include human-based in vitro models of tissue and disease, chemical biology for predicting drug and toxicity mechanisms of action and phenotypic drug discovery.
Systems Biology Approach to Cancer
Shannon Hughes, Program Director, Cancer Systems Biology Consortium, National Cancer Institute, United States
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Dr. Hughes received a BS in Chemical Engineering from Iowa State University and a PhD in biomedical engineering at Washington University in St. Louis, before obtaining a DOD Breast Cancer Research Postdoctoral Fellowship at MIT. Dr Hughes joined the National Cancer Institute’s Division of Cancer Biology in 2015 as a Program Director for the Cancer Systems Biology Consortium and the Physical Sciences in Oncology Network. She currently manages the Cancer Systems Biology Consortium, NCI’s main effort to tackle complex questions in cancer through the explicit integration of mathematical and computational approaches with experimental biology.
A network based approach to understanding drug toxicity and its application to human liver disease
Jeff Sutherland, Consultant, Indiana Biosciences Research Institute, United States
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Dr. Sutherland received his undergraduate degree in chemistry from Laurentian University, his doctorate in chemistry at Queen’s University and completed postdoctoral research at Eli Lilly. He has held positions in research IT at Lilly, managing scientists working in all areas of drug discovery and development, and was research advisor in Tailored Therapeutics at Eli Lilly and Company. He is vice president of analytics at Sano Informed Prescribing, a startup developing diagnostics tests for the optimization of drug therapy, and also acts as a consultant for the Indiana Biosciences Research Institute on the development of a web platform for systems toxicology.
Integrated Systems Approaches to Understand and Predict Cancer Treatment Related Adverse Drug Events
Darrell Abernathy, Associate Director for Drug Safety, Department of Health and Human Safety, FDA, United States
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Dr. Abernethy earned his MD and PhD from the University of Kansas School of Medicine. In addition to his work at FDA, he was a professor of medicine (geriatrics) and of pharmacology and molecular science (part–time) at the Johns Hopkins University School of Medicine. In his role as Associate Director for Drug Safety and lead for the biosimilars program in the Office of Clinical Pharmacology, he was responsible for leading the development of a pharmacological mechanism-based safety program in the Office of Clinical Pharmacology to work in synergy with efforts in the Office of Surveillance and Epidemiology and other Offices and Centers at FDA.